Review of general EU pharmaceutical legislation – public consultation now open | Hogan Lovells



The European Commission this afternoon opened the public consultation on general EU pharmaceutical legislation on medicines for human use. This initiative is part of the EU Pharmaceutical Strategy for Europe and invites stakeholders and members of the general public to share their views on issues such as unmet medical needs, incentives for innovation , rules for new products, affordability of drugs and more.

The Commission is evaluating Directive 2001/83 / EC establishing a Community code relating to medicinal products for human use and Regulation (EC) No 726/2004 establishing Community procedures for the authorization and monitoring of medicinal products for human and veterinary use and establishing a European Medicines Agency (collectively, the “general EU pharmaceutical legislation”).

This revision proposes to fill the gaps in the general pharmaceutical legislation of the EU in areas previously identified.

Stakeholders and members of the general public can contribute to the assessment of the legislation by completing a questionnaire made available today in this page.

The main topics covered in the questionnaire are:

  • The performance of current EU general pharmaceutical legislation;
  • Unmet medical needs (a definition or set of principles for “unmet medical needs” is under discussion);
  • Incentives for innovation (including views on regulatory data and market protections);
  • Antimicrobial resistance;
  • Adapted, agile and predictable regulatory framework for new products (future proofing);
  • Improved access to medicines (rewards and obligations);
  • Affordability of medicines (including views on measures to support patients’ access to affordable medicines);
  • Reallocation of drugs;
  • Security of drug supply;
  • Quality and manufacturing (including views on strengthening or adapting GMP to reflect new manufacturing methods); and
  • Environmental challenges.

Next steps

The deadline for participating in the public consultation is December 21, 2021 (midnight Brussels time). The summary of the contributions of the public consultation will then be published on the “Have your say” portal.

A proposal for a regulation from the European Commission is scheduled for the fourth quarter of 2022.

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